Regulation of Natural Health Products in Canada

What is a natural health product (NHP)?

A natural health product (NHP) is a naturally occurring substance that is used to restore or maintain good health. It can be made from plants, animals, microorganisms, or marine sources. In Canada, all natural health products are regulated by Health Canada.

The Natural Health Products Regulations of Health Canada defines natural health products (NHPs) as vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines (e.g., traditional Chinese medicines), probiotics, amino acids and essential fatty acids, or other specific products. Certain toothpastes, antiperspirants, shampoos, facial products, and mouthwashes are also classified as natural health products.

Natural health product licensing

In order to sell a natural health product in Canada, the manufacturer must apply to the Natural and Non-prescription Health Products Directorate of Health Canada and provide the following information: medicinal ingredients, source, dose, potency, non-medicinal ingredients, and recommended use. Safety, efficacy, and health claims of NHPs must be supported by proper evidence such as clinical trial data or references to published studies, journals, pharmacopoeias, or traditional resources. The amount and source of information depends on the proposed health claim and overall risk.

If Health Canada approves an NHP, it must get a product licence, a site licence (where it is produced, if in Canada), and an eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM).

Labelling requirements

All natural health products must meet specific labelling requirements, which include, but are not limited to, the following information:

• Product name
• Product licence number — Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM)
• Quantity of product in container
• A complete list of medicinal and non-medicinal ingredients
• Recommended use, including purpose or health claim, route of administration, and dose
• Any cautionary statements, warnings, contra-indications, and possible adverse reactions associated with the product
• Any special storage conditions